EP1765309B1 - Rauchloses tabakprodukt - Google Patents

Rauchloses tabakprodukt Download PDF

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Publication number
EP1765309B1
EP1765309B1 EP05752156A EP05752156A EP1765309B1 EP 1765309 B1 EP1765309 B1 EP 1765309B1 EP 05752156 A EP05752156 A EP 05752156A EP 05752156 A EP05752156 A EP 05752156A EP 1765309 B1 EP1765309 B1 EP 1765309B1
Authority
EP
European Patent Office
Prior art keywords
vehicle
smokeless tobacco
tobacco product
product according
anyone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Revoked
Application number
EP05752156A
Other languages
English (en)
French (fr)
Other versions
EP1765309A1 (de
Inventor
Thomas ENGSTRÖM
Torbjörn MATHISEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
IDAR MEDICAL BIODEGRADABLE AB
Original Assignee
Radi Medical Biodegradable AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35783173&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1765309(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from SE0401721A external-priority patent/SE0401721D0/xx
Application filed by Radi Medical Biodegradable AB filed Critical Radi Medical Biodegradable AB
Publication of EP1765309A1 publication Critical patent/EP1765309A1/de
Application granted granted Critical
Publication of EP1765309B1 publication Critical patent/EP1765309B1/de
Anticipated expiration legal-status Critical
Revoked legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/24—Treatment of tobacco products or tobacco substitutes by extraction; Tobacco extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/465—Nicotine; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Definitions

  • the present invention relates generally to a smokeless tobacco product in the form of a completely dissolvable vehicle comprising concentrated tobacco extract contained in a dissolvable matrix.
  • Smokeless tobacco e.g. so called “snuff”
  • smokeless tobacco is widely used as substitute for cigarettes, cigars and other forms of smoking-tobacco as it poses comparatively less health risks to the user.
  • Many people do also use a smokeless alternative during a transition period to reduce the acute abstinence from nicotine that may results from a sudden refraining from cigarettes.
  • the general object of the present invention is to provide a more appealing administration form for smokeless tobacco.
  • Another object of the invention is to provide a vehicle that, in the mouth of a user, releases flavours coming from tobacco extracts as well as other substances, which vehicle provides for a controlled release and thereby intake of these flavours and substances.
  • a further object is to provide a three-dimensional vehicle which in the mouth of a user creates a three-dimensional sensation.
  • a dissolvable vehicle comprising a water-soluble polymer matrix in which tobacco extract has been incorporated, wherein the dissolvable vehicle is a multilayer vehicle and the dissolvable polymeric matrix constitutes at least one of the several layers.
  • the tobacco extract has been freed from any type of insoluble residue, and the whole vehicle will therefore dissolve within the mouth of a user. The necessity of an unpleasant and discomfortable removal of a saliva-soaked tobacco pouch is thereby eliminated.
  • the dissolvable vehicle is a three-dimensional vehicle, which in the mouth of a user creates a three-dimensional sensation.
  • the dissolvable three-dimensional vehicle has a multilayer structure, with at least one layer comprising a water-soluble polymer matrix in which concentrated tobacco extract has been incorporated.
  • Another layer of the three-dimensional vehicle may comprise different kinds of flavours, additives, and other drugs such as nicotine.
  • a multilayered three-dimensional vehicle is adapted to dissolve layer by layer, thereby providing for a controlled release and subsequent intake of the drugs and flavours contained in the respective layers.
  • the present invention relates to a smokeless tobacco product in the form of a dissolvable vehicle comprising a water-soluble polymer matrix containing concentrated tobacco extract, wherein the dissolvable vehicle is a multilayer vehicle and the dissolvable polymeric matrix constitutes at least one of the several layers.
  • the polymer matrix is made from any type of water-soluble polymer, including both synthetic and naturally occurring polymeric substances.
  • the matrix is formulated to optimize the leaching process of the various flavour substances found in tobacco extracts.
  • the dissolvable vehicle is a body with significant extensions in all three dimensions, such that the dissolvable vehicle at the start of the dissolution process creates a three-dimensional feeling in a user's mouth.
  • suitable water-soluble polymers are various proteins such as collagen or fibrin, and various carbohydrates like alginates, guar gum, agarose, as well as various types of glucosamino-glucanes and cellulose. It can be noted that most of these carbohydrates can be chemically substituted to significantly alter their properties.
  • Various types of polymeric alcohols such as polyethylene glycols, polypropylene glycols, and polyvinyl alcohols, can be used to formulate the water-soluble matrix as well as polypyrollidone, and various polymeric acrylic acids and ionomers.
  • polyethylene glycols polypropylene glycols
  • polyvinyl alcohols can be used to formulate the water-soluble matrix as well as polypyrollidone, and various polymeric acrylic acids and ionomers.
  • Several of the alternatives listed above can be cross-linked in various degrees to achieve alterations in their dissolution properties. It is further possible to incorporate various types of non-ionic, cationic and/or anionic substituents in the polymer matrix to
  • the dissolvable vehicle is a multilayer vehicle.
  • One of the layers, preferably the outermost layer, can comprise a component with a certain degree of mucoadhesive properties.
  • An example of such a mucoadhesive substance is chitosan.
  • a mucoadhesive layer would adhere to the mucosa in the mouth of a user, and thereby act as a fixation for the vehicle.
  • Such a mucoadhesive substance could also promote the penetration of tobacco flavours into the mucosa.
  • soluble or “dissolvable” are meant to encompass all types of disintegrating, dissolving, resorbing, absorbing and eroding processes that can occur in a vehicle that in a user's mouth dissolves in such a way that a removal from the mouth and a subsequent disposal of a vehicle rest by hand are not necessary after the tobacco flavours have been extracted.
  • the different substances mentioned above are therefore merely illustrative examples of various ingredients that could be used to formulate a self-disintegrating matrix that constitute a base for a dissolvable vehicle for a smokeless tobacco product.
  • the smokeless tobacco product of the present invention is based on concentrated tobacco extract, which can be extracted by several methods well-known in the art.
  • Tobacco extract is perhaps most easily prepared by treating tobacco with water, or water containing a small amount of an organic solvent.
  • the preferred temperature for extraction is room temperature, but any temperature in the range of 10 °C to 60 °C will work.
  • the pH-value and ionic strength can be adjusted to depress or promote extraction of certain tobacco substances.
  • Supercritical carbon dioxide has, for example, been successfully employed to produce tobacco extracts that are diminished in nicotine.
  • the tobacco extract may include extracts from all original substances of the tobacco plant or a subset thereof, including one or many original substance(s).
  • the tobacco extract may be a synthetically prepared substance having essentially equivalent characteristics as the corresponding extract from the tobacco plant.
  • the extract may include both one or many original (natural) substance(s) and one or many synthetic substance(s).
  • the tobacco extract is nicotine or synthetically prepared nicotine, being the only substance or used in combination with other substances.
  • Fig. 1 illustrates a first and basic embodiment of a smokeless tobacco product.
  • the tobacco product comprises a vehicle 1, which is made from a water-soluble polymeric matrix in which tobacco extract has been included.
  • the polymeric matrix can be made from any of the polymers listed above.
  • One way to formulate such a tobacco-containing polymeric matrix would be to dissolve one or several suitable polymers in a water-solution of tobacco extracts. The solution is then dried to a suitable matrix form. During the drying process the polymers can optionally be cross-linked to alter their dissolution properties.
  • a polymer material to be used in the present invention should preferably be soft; it could, for example, have a compression modulus less than 0.1 MPa.
  • the polymer material can have a dissolution time ranging from about 5 minutes to about 60 minutes, and preferably from approximately 10 minutes to approximately 30 minutes.
  • a vehicle 11 for a smokeless tobacco product is shown.
  • the vehicle 11 is a multi-layer vehicle that comprises an inner layer 12, an intermediate layer 13, and an outer layer 14.
  • the inner layer 12 comprises a water-soluble polymeric matrix in which tobacco extract has been included.
  • the matrix can be formulated in the same way as suggested in conjunction with Fig. 1 , or the polymeric matrix can be in the form of a porous or fibrous matrix in which dry tobacco extract or water-dissolved tobacco extract is incorporated.
  • the intermediate layer 13 can then serve as a cover or seal that encapsulates the tobacco extract inside the polymeric matrix.
  • the intermediate layer 13 can further comprise a swelling substance that absorbs saliva and thereby increases the volume of the vehicle 11.
  • the outer layer 14 can comprise an adhesive, such as chitosan, which adhere to the mucosa in a user's mouth, and thereby fixates the vehicle 11 inside the user's mouth.
  • the outer layer 14 can also comprise a substance that facilitates the penetration of the flavours and other drugs and substances into the mucosa.
  • the structure of the vehicle 11 is only exemplifying, and it should in particular be recognized that more layers could be added, and that the contents of each layer could be altered such that, for example, the swelling substance is in the innermost layer, while the tobacco extract is contained in an intermediate layer.
  • the different layers of the multilayer vehicle can be based on the same polymer matrix, the only difference being that different additives, such as drugs and flavours, are included in the different layers, with at least one layer containing the tobacco extract.
  • Another possibility is to prepare a special polymeric matrix for each layer to thereby make it easy to control the dissolution of the layer and the release of substances therefrom.
  • one layer e.g. the outermost layer, in the form of a dragée, which further can comprise a substance which renders this layer a special effect on the user.
  • An advantage of having a multilayer vehicle is that the separate layers can be adapted to dissolve sequentially in a user's mouth.
  • on outer layer is essentially disintegrated before an inner layer starts to dissolve. It is thereby easy to control the affect that the present vehicle has on a user.
  • the outermost layer could include a high concentration of nicotine, as the desire for nicotine presumably is at the highest just after the user has put the vehicle in his or her mouth, while a more interior layer could include a lower concentration of nicotine, when the user's urge for nicotine has been almost satisfied. The total intake of nicotine could thereby be reduced.
  • the present invention is not restricted to any particular dimensions of a vehicle for a smokeless tobacco product.
  • the vehicle can, for example, be in the form of an essentially two-dimensional structure such as a thin sheet or patch. It is, however, the present inventors' belief that for some people it is important that a smokeless tobacco product for oral administration is capable of creating a three-dimensional sensation in the mouth of a user.
  • the term "three-dimensional" is defined as a dimensional relationship that creates a three-dimensional sensation in a user's mouth.
  • the vehicle for the tobacco extract has therefore a first dimension (e.g. a length), a second dimension (e.g. a width) and a third dimensions (e.g. a height), and is characterized in that none of the three dimensions is negligible in comparison with one of the other two dimensions.
  • a first dimension e.g. a length
  • a second dimension e.g. a width
  • a third dimensions e.g. a height
  • a vehicle for the mucosal administration of tobacco extracts has a length denoted by A, a width denoted by B, and a height denoted by C, and if A is larger than (or equal to) B, then C should be at least one tenth of A (i.e. C/A ⁇ 1/10), preferably C/A ⁇ 1/7.
  • a suitable interval for C/A could be 1/8 ⁇ C/A ⁇ 1/2.
  • Fig. 3 shows a schematic view of the vehicle according to the present invention.
  • A is about 30 mm
  • B is about 15 mm
  • C is about 5 mm, such that C/A ⁇ 1/6.
  • a vehicle according to the present invention is pillow-shaped, and provided with rounded corners and/or edges, as can be seen in Fig. 1 or Fig. 2 .
  • the three-dimensional sensation referred to above relates to a three-dimensional sensation created when the vehicle has been placed in the mouth of a user.
  • the vehicle can be essentially two-dimensional before it is placed in the user's mouth. This would in particular apply to a vehicle comprising a swelling substance. Such a vehicle would then perhaps not fulfil the above criteria for A, B and C before it has been placed in the mouth, but would fulfil these criteria shortly after it has come into contact with salvia. Also such vehicles are considered to be three-dimensional vehicles.
  • a vehicle containing tobacco extract can comprise a large variety of different drugs.
  • a drug is nicotine, which can be included in different, selectable concentrations in different versions of the smokeless tobacco product of the present invention.
  • the nicotine concentration could, for example, range from a high concentration to zero, such that people, e.g. inveterate smokers, gradually can reduce their daily intake and finally get rid of their nicotine addiction.
  • the smokeless tobacco product could also be flavoured with extra flavours, such as liquorice, menthol, spearmint or peppermint. It is also possible to add vitamins and minerals to create a healthier product. More dedicated drugs could also be added. Examples of such drugs would be flour or a suitable teeth-whitening substance, or a substance that cures halitosis, or some other type of nature-cure drug.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Manufacture Of Tobacco Products (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (13)

  1. Rauchloses Tabakprodukt in Form eines löslichen Vehikels (1; 11) zur oralen Verabreichung, wobei das Vehikel dadurch gekennzeichnet ist, daß das Vehikel eine lösliche polymere Matrix umfaßt, die Tabakextrakt oder ein synthetisches Äquivalent davon enthält, und wobei es sich bei dem löslichen Vehikel um ein mehrschichtiges Vehikel (11) handelt und die lösliche polymere Matrix wenigstens eine der mehreren Schichten (12, 13, 14) bildet.
  2. Rauchloses Tabakprodukt nach Anspruch 1, dadurch gekennzeichnet, daß es sich bei dem Tabakextrakt um getrockneten Tabakextrakt handelt.
  3. Rauchloses Tabakprodukt nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß die äußerste Schicht eine mucoadhäsive Substanz enthält.
  4. Rauchloses Tabakprodukt nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß wenigstens eine Schicht eine Substanz enthält, die, wenn sie mit Speichel in Kontakt kommt, aufquillt.
  5. Rauchloses Tabakprodukt nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß sich das mehrschichtige Vehikel im wesentlichen Schicht für Schicht im Mund eines Anwenders auflöst.
  6. Rauchloses Tabakprodukt nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, daß das Vehikel eine im wesentlichen zweidimensionale Form aufweist.
  7. Rauchloses Tabakprodukt nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß es sich bei dem Vehikel um ein dreidimensionales Vehikel handelt bzw. daß das Vehikel, wenn es in den Mund eines Anwenders gegeben wird, zu einem dreidimensionalen Vehikel aufquillt, welches eine erste Dimension A, eine zweite Dimension B und eine dritte Dimension C hat, wobei A ≥ B ≥ C und C/A ≥ 1/10.
  8. Rauchloses Tabakprodukt nach Anspruch 7, dadurch gekennzeichnet, daß 1/8 ≤ C/A ≤ 2/3.
  9. Rauchloses Tabakprodukt nach Anspruch 8, dadurch gekennzeichnet, daß 1/7 ≤ C/A ≤ 1/2.
  10. Rauchloses Tabakprodukt nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, daß das Vehikel ein Kompressionsmodul von weniger als 0,1 MPa hat.
  11. Rauchloses Tabakprodukt nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, daß das Vehikel eine Auflösungszeit im Bereich von 5 bis 60 Minuten, vorzugsweise im Bereich von 10 bis 30 Minuten, hat.
  12. Rauchloses Tabakprodukt nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, daß der Extrakt nikotinfrei ist.
  13. Rauchloses Tabakprodukt nach einem der Ansprüche 1-11, dadurch gekennzeichnet, daß es sich bei dem Extrakt um Nikotin oder synthetisch hergestelltes Nikotin handelt.
EP05752156A 2004-07-02 2005-06-08 Rauchloses tabakprodukt Revoked EP1765309B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US58449404P 2004-07-02 2004-07-02
SE0401721A SE0401721D0 (sv) 2004-07-02 2004-07-02 Drug releasing three-dimensional vehicle
PCT/SE2005/000864 WO2006004480A1 (en) 2004-07-02 2005-06-08 Smokeless toabacco product

Publications (2)

Publication Number Publication Date
EP1765309A1 EP1765309A1 (de) 2007-03-28
EP1765309B1 true EP1765309B1 (de) 2009-08-05

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ID=35783173

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EP05752156A Revoked EP1765309B1 (de) 2004-07-02 2005-06-08 Rauchloses tabakprodukt

Country Status (5)

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US (1) US20080196730A1 (de)
EP (1) EP1765309B1 (de)
AT (1) ATE438390T1 (de)
DE (1) DE602005015854D1 (de)
WO (1) WO2006004480A1 (de)

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Also Published As

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WO2006004480A1 (en) 2006-01-12
EP1765309A1 (de) 2007-03-28
US20080196730A1 (en) 2008-08-21
DE602005015854D1 (de) 2009-09-17
ATE438390T1 (de) 2009-08-15

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